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Questions and Answers
Calculate the DSV and determine the BCS class of drug product Zenitsu.
Calculate the DSV and determine the BCS class of drug product Zenitsu.
volume; BCS Class X
Drug product Miraidon is a film-coated tablet containing 100 mg.
Drug product Miraidon is a film-coated tablet containing 100 mg.
True (A)
What was the outcome of the Bioequivalence Studies for Miraidon?
What was the outcome of the Bioequivalence Studies for Miraidon?
- No studies were conducted.
- Results were above the acceptance criteria.
- Results were below the acceptance criteria.
- Results were within the acceptance criteria. (correct)
Calculate the DSV and determine the BCS class of the drug product Zenitsu.
Calculate the DSV and determine the BCS class of the drug product Zenitsu.
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What is the solubility of drug product Zenitsu in 0.1 N HCl at pH 2?
What is the solubility of drug product Zenitsu in 0.1 N HCl at pH 2?
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The drug product Miraidon has undergone Bioequivalence Studies.
The drug product Miraidon has undergone Bioequivalence Studies.
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The film-coated tablet of drug product Miraidon contains ______ mg of drug.
The film-coated tablet of drug product Miraidon contains ______ mg of drug.
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Study Notes
Drug Product Zenitsu
- Available strengths: 8 mg, 16 mg, and 32 mg.
- Absorption rate: 65%.
- Solubility data provided for various pH levels and media:
- 0.1 N HCl, pH 1: Solubility is 0.0472 g/mL.
- 0.1 N HCl, pH 2: Solubility is 0.0492 g/mL.
- 0.15 M acetate buffer, pH 4: Solubility is 0.0568 g/mL.
- 0.15 M phosphate buffer, pH 6: Solubility is 0.0608 g/mL.
- 0.15 M phosphate buffer, pH 8: Solubility is 0.0560 g/mL.
- Drug's DSV (Dose Solubility Volume) needs to be calculated for classification.
- BCS (Biopharmaceutical Classification System) class determination follows solubility and absorption characteristics.
Drug Product Miraidon
- Formulation: Film-coated tablet containing 100 mg of active pharmaceutical ingredient (API).
- Underwent Bioequivalence Studies with a comparator drug.
- Results of Bioequivalence Studies met acceptance criteria outlined in the study protocol.
Drug Product Zenitsu
- Available strengths: 8 mg, 16 mg, and 32 mg.
- Absorption rate: 65%.
- Solubility data provided for various pH levels and media:
- 0.1 N HCl, pH 1: Solubility is 0.0472 g/mL.
- 0.1 N HCl, pH 2: Solubility is 0.0492 g/mL.
- 0.15 M acetate buffer, pH 4: Solubility is 0.0568 g/mL.
- 0.15 M phosphate buffer, pH 6: Solubility is 0.0608 g/mL.
- 0.15 M phosphate buffer, pH 8: Solubility is 0.0560 g/mL.
- Drug's DSV (Dose Solubility Volume) needs to be calculated for classification.
- BCS (Biopharmaceutical Classification System) class determination follows solubility and absorption characteristics.
Drug Product Miraidon
- Formulation: Film-coated tablet containing 100 mg of active pharmaceutical ingredient (API).
- Underwent Bioequivalence Studies with a comparator drug.
- Results of Bioequivalence Studies met acceptance criteria outlined in the study protocol.
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